RxNews Recap for Wednesday 03-03-10. Dendreon and Santarus surge after the bell. Print E-mail
By BioMedReports.com Staff   
Wednesday, 03 March 2010 19:16

Below is a list of the companies that made news in the healthcare sector on Wednesday, March 3, 2010.

Dendreon Corporation (Nasdaq:DNDN) saw its shares leap after hours as the company announced updated results from its pivotal Phase 3 IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) study demonstrating that PROVENGE® (sipuleucel-T) extends overall survival in men with metastatic, castrate-resistant (hormone-refractory) prostate cancer (CRPC). The data will be presented at the American Society of Clinical Oncology 2010 Genitourinary Cancers Symposium (ASCO-GU) in San Francisco on Friday, March 5 at 1:45 pm PT.

A sensitivity analysis performed with longer-term follow-up (36.5 months) and additional events (349 deaths) collected at the time of study closure demonstrated that PROVENGE increased three-year survival by 40 percent compared to placebo (32.1 percent vs 23.0 percent), the median survival difference of PROVENGE compared to placebo was maintained at 4.1 months, with a 24.1 percent reduction in the risk of death [HR=0.759] and a p-value of 0.017.

As previously reported in a primary analysis (34.1 months median follow-up; 331 deaths), the IMPACT study met its pre-specified primary endpoint of significantly improving overall survival compared to placebo, demonstrating that PROVENGE increased three-year survival by 38 percent compared to placebo (31.7 percent vs 23.0 percent), extending median survival by 4.1 months compared to placebo (25.8 months vs. 21.7 months), with a 22.5 percent reduction in the risk of death [HR=0.775] and a p-value of 0.032.

In addition, new analyses demonstrated that the median predicted survival of the two treatment arms using the Halabi model were well balanced (20.3 months for PROVENGE vs 21.2 months for placebo). Furthermore, in an analysis in which patients were censored at the time of docetaxel use, the PROVENGE treatment effect remained strong [HR=0.649].

DNDN was up $1.36 to $34.98 in the after hours market.

Santarus, Inc. (NASDAQ:SNTS), a specialty biopharmaceutical company, shot up after hours when the company reported financial and operating results for the quarter and full year ended December 31, 2009.

Key financial results for the 2009 fourth quarter: *Product-related revenue of $38.9 million compared with $34.8 million for the prior year period. * Total revenues of $62.4 million compared with 2008 fourth quarter total revenues of $37.5 million. * Net income of $24.5 million, or $0.40 per diluted share, compared with a net loss of $10.2 million, or $0.19 per share, in the fourth quarter of 2008.* Total revenues and net income reflected the positive impact of a $20 million milestone earned in December 2009 related to the U.S. Food and Drug Administration (FDA) approval of ZEGERID OTC™ (omeprazole 20 mg/sodium bicarbonate 1100 mg capsules).

Key financial results for the 2009 full year: * Product-related revenue of $142.9 million increased 29% compared with $111.0 million in the prior year.* Total revenues of $172.5 million increased 32% compared with 2008 total revenues of $130.2 million. * Net income of $32.1 million, or $0.54 per diluted share, compared with a net loss of $18.5 million, or $0.36 per share, in 2008.* Positive cash flow from operations of $37.0 million. * Cash, cash equivalents and short-term investments of $93.9 million as of December 31, 2009.

"We are pleased to report our first full year of profitability," said Debra P. Crawford, senior vice president and chief financial officer of Santarus. "We grew 2009 product-related revenue by 29%, while reducing total costs and expenses by 7% compared with the prior year. Our strong operating results were further enhanced by the $20 million milestone relating to FDA approval of ZEGERID OTC."

Shares of Santarus traded higher by 30 cents or 6.82% in the after hours session.

In news from earlier in the day:

Abbott (NYSE:ABT) announced today that it has entered into an agreement with GlaxoSmithKline (GSK) to develop a molecular diagnostic test intended for use as an aid in selecting patients who may benefit from a skin cancer treatment in development by GSK.

Abraxis BioScience, Inc. (NASDAQ: ABII), a fully integrated biotechnology company, today announced Sanjay Gupta has been chosen by the World Economic Forum for its 2010 class of Young Global Leaders.

Adolor Corporation (NasdaqGM:ADLR) today announced that Michael R. Dougherty, President and Chief Executive Officer, will present at the Cowen and Company 30th Annual Health Care Conference on Tuesday, March 9, 2010, at 1:45 P.M. Eastern Time.

Affymetrix, Inc. (NASDAQ:AFFX) announced today that Jami Dover Nachtsheim and Nelson C. Chan have been appointed to the board of directors, effective March 8, 2010.

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, today announced that management will present a company overview at Cowen and Company’s 30th Annual Health Care Conference on Tuesday, March 9, 2010, at 4:30 p.m. ET at the Boston Marriott Copley Place.

Amarin Corporation plc (Nasdaq: AMRN) today announced that John F. Thero, Chief Financial Officer, is scheduled to present at Cowen and Company's 30th Annual Healthcare Conference on Wednesday, March 10, 2010 at 8:45 am Eastern Time.

ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that it will present at the 30th Annual Cowen Healthcare Conference being held at the Boston Marriot Copley Place in Boston, Massachusetts. Harvey J. Berger, M.D., chairman and chief executive officer at ARIAD, will provide an overview of the Company and its progress in key programs on Wednesday, March 10, 2010 at 8:00 a.m. (ET).

Avisio, Inc. (PINKSHEETS: AVIC) announced today that it has engaged Silberstein Ungar, PLLCto serve as Avisio's independent auditors.

Beckman Coulter, Inc. (NYSE:BEC), a leading developer, manufacturer, and marketer of products that simplify, automate, and innovate complex biomedical testing, announced today that Scott Garrett, Beckman Coulter's chairman, president and chief executive officer, will present at the Cowen Healthcare Conference on Tuesday, March 9, 2010, at 10:20 a.m. ET.

Biomoda, Inc. (OTCBB: BMOD) (www.biomoda.com) and Advanced Medical Imaging and Genetics (Amigenics) (www.amigenics.com), an innovative medical clinic specializing in prevention and early detection of disease, announced their intent to collaborate on a variety of projects to advance technology for the early detection of lung and other cancer.

Bruker Corporation (NASDAQ: BRKR) announced today that it will present at the 30th Annual Cowen & Company Healthcare Conference on Wednesday, March 10th, 2010, at 8:45 a.m. Eastern Time at the Boston Marriott Copley Place.

Celera Corporation (NASDAQ:CRA) today reported net revenues of $40.0 million for the fourth quarter of 2009 that ended December 26, 2009, compared to $47.3 million in the prior year quarter.

China Sky One Medical, Inc. (Nasdaq: CSKI), a leading fully integrated pharmaceutical company producing over-the-counter drugs in the People's Republic of China ("PRC"), today announced that Mr. Yanqing Liu, the Company's CEO, and Mr. Stanley Hao, CFO, will present at the upcoming Rodman & Renshaw Annual China Investment Conference to be held on March 7-9, 2010.

Covidien (NYSE: COV), a leading global provider of healthcare products, today announced that Mallinckrodt Inc., a Covidien company, has launched its Oral Transmucosal Fentanyl Citrate (CII) to distributors serving retail pharmacies across the country.

CryoPort, Inc. (OTCBB: CYRXD) announces that the warrants attached to its recently completed Public Offering commenced trading today on the OTCBB under the ticker symbol CYPTW.

DUSA Pharmaceuticals, Inc.® (NASDAQ GM: DUSA), a dermatology company that is developing and marketing Levulan® Photodynamic Therapy (PDT) and other products focused on patients with common skin conditions, reported today its corporate highlights and financial results for the fourth quarter and full year ended December 31, 2009.

Illumina, Inc. (NASDAQ:ILMN) today announced that the company will webcast its presentations at two upcoming investment conferences.

Insmed Inc. (Nasdaq: INSM), a biopharmaceutical company, today announced that it will host a conference call on Monday, March 15th, at 8:30 AM ET, to discuss its financial results for the fourth quarter and year-end 2009.

Interleukin Genetics, Inc. (NYSE Amex: ILI) announced presentation of findings from a retrospective clinical study on weight management conducted in collaboration with Stanford University. The study results and conclusions were presented today by investigators from Stanford Prevention Research Center at Stanford University School of Medicine during an oral presentation titled "Genotype Patterns Predict Weight Loss Success: The Right Diet Does Matter," at the American Heart Association's Joint 50th Cardiovascular Disease Epidemiology and Prevention – and – Nutrition, Physical Activity and Metabolism conference, being held March 2-5 in San Francisco, CA.

MedPro Safety Products, Inc. (OTCBB: MPSP), a leading developer of transformational technologies that enable safer medication delivery and blood collection system, announced today that it will present at the Cowen and Company 30th Annual Health Care Conference on Monday, March 8, 2010 at The Boston Marriott Copley Place in Boston, Massachusetts.

Medtronic, Inc. (NYSE: MDT) was named today to the 11th annual “100 Best Corporate Citizens List” published by Corporate Responsibility magazine (formerly known as CRO magazine).

NicOx S.A. (NYSE Euronext Paris: COX) and Bausch + Lomb, a leading eye health company, today announced the companies have entered into a licensing agreement which grants Bausch + Lomb exclusive worldwide rights to develop and commercialize NCX 116 (previously PF-03187207), a nitric oxide-donating prostaglandin F2-alpha analog.

Nile Therapeutics, Inc. (NASDAQ:NLTX), a biopharmaceutical company in the development of novel therapeutics for heart failure patients, today announced its fourth quarter and full year financial results for 2009.

NPS Pharmaceuticals, Inc. (Nasdaq: NPSP) announced today that it will report its 2009 financial results on Thursday, March 11, 2010 at approximately 4:30 p.m. ET.

Optimer Pharmaceuticals, Inc. (Nasdaq: OPTR) today announced it expects to report fourth quarter and full year 2009 financial results after the NASDAQ Global Market closes on Thursday, March 11, 2010.

Pfizer Inc. (NYSE: PFE) and Medivation, Inc. (NASDAQ: MDVN) today announced results from two Phase 3 trials of the investigational drug dimebon (latrepirdine*) in patients with Alzheimer’s disease (AD).

PDI, Inc. (Nasdaq: PDII), a leading provider of sales and marketing support to U.S. health care companies, today announced that David Kerr, senior vice president of business development, is scheduled to present at the ROTH Capital Partners 22nd Annual OC Growth Stock Conference at 12:30 pm PT on March 17, 2010 at The Ritz-Carlton Laguna Nigel in Dana Point, CA.

PPD, Inc. (Nasdaq: PPDI) today announced it has achieved national Gold Well Workplace designation by Wellness Councils of America (WELCOA), becoming one of only two North Carolina companies honored in 2009 for its commitment to protecting and enhancing the health and well-being of its employees.

Protalix BioTherapeutics, Inc. (NYSE-Amex: PLX), announced today that the Israeli Ministry of Health has completed a successful GMP (Good Manufacturing Practice) audit of the Company's manufacturing facility in Carmiel, Israel. The audit was performed as part of the Ministry of Health's evaluation of the company's manufacturing process of taliglucerase alfa for the treatment of Gaucher disease.

"The successful audit of our manufacturing facility by the Israeli Health Ministry is another important milestone toward our plans to commercialize taliglucerase alfa in Israel and throughout the world," said Dr. David Aviezer, President and CEO of Protalix. "This important achievement helps to demonstrate the viability, quality and commercial potential of our proprietary plant-cell based technology platform."

pSivida Corp. (NASDAQ:PSDV) (ASX:PVA) (FF:PV3), a leader in the development of ophthalmic sustained release drug delivery products, with two of the only three such products approved by the FDA for treatment of back of the eye diseases, today said that 24-month data from the FAME Phase 3 study for Iluvien presented at Angiogenesis 2010 included additional efficacy and safety data that reinforced the positive top-line results reported in December 2009 by pSivida and its licensee, Alimera Sciences, Inc.

PTC Therapeutics, Inc. and Genzyme Corporation (Nasdaq: GENZ) today announced preliminary results from the Phase 2b clinical trial of ataluren, an investigational new drug, in patients with nonsense mutation Duchenne/Becker Muscular Dystrophy (nmDBMD).

Repligen Corporation (Nasdaq:RGEN) announced today that it has acquired the assets of BioFlash Partners, LLC, (BioFlash) including a technology platform for the production of pre-packed, "plug and play" chromatography columns. This patented technology enables economical production of chromatography columns in a format that is ready for use in the production of a broad range of biopharmaceuticals including monoclonal antibodies, vaccines and recombinant proteins. The terms of the acquisition include an upfront payment of $1.8 million, a contingent milestone and royalties based on product sales. A product offering based on this technology is being launched this week at the IBC Biopharmaceutical Development and Production conference under the brand name Opus(TM). The global market for chromatography media used in the production of biopharmaceuticals is estimated to be approximately $500 million.

Santarus, Inc. (NASDAQ:SNTS), a specialty biopharmaceutical company, today reported financial and operating results for the quarter and full year ended December 31, 2009.

Seattle Genetics, Inc. (Nasdaq: SGEN) announced today that it has achieved a milestone under its antibody-drug conjugate (ADC) collaboration with Genentech, Inc., a wholly owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY). The milestone was triggered by Genentech’s submission of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for an ADC utilizing Seattle Genetics’ technology for the treatment of cancer.

Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, announced that Marc N. Casper, president and chief executive officer, will present at the 30th Annual Cowen and Company Healthcare Conference being held at the Boston Marriott Copley Place in Boston, Mass.

Tianyin Pharmaceutical Co., Inc. (NYSE Alternext: TPI), a manufacturer and supplier of modernized traditional Chinese medicine ("TCM") based in Chengdu, China, today announced it will present at the Rodman & Renshaw Annual China Investment Conference being held March 7-9 in Beijing, China.

Transition Therapeutics Inc. (TSX:TTH) (Nasdaq:TTHI) rose today after the company announced that it has acquired the rights to a series of preclinical compounds from Eli Lilly and Company in the area of diabetes. Under the licensing and collaboration agreement, Transition will receive exclusive worldwide rights to develop and potentially commercialize a class of compounds that, in preclinical diabetes models showed potential to provide glycemic control and other beneficial effects including weight loss.

"We are very pleased to expand our current relationship with Lilly through the acquisition of these preclinical assets," said Dr. Tony Cruz, Chairman and Chief Executive Officer of Transition. "The addition of these novel compounds leverages our expertise in metabolic diseases and grows our development pipeline with next generation diabetes therapies."

Urigen Pharmaceuticals, Inc. (OTCBB: URGP), a specialty pharmaceutical company focused on the development of treatments for urological disorders and pain, announced today that Edward R. Teitel, MD, JD has been elected Chairman of the Board of Directors.

Uroplasty, Inc. (NYSE Amex: UPI) highlighted results from a two-year, multicenter clinical study of Macroplastique that will be published in the April 2010 print edition of The Journal of Urology(R). The 24-month study evaluated the durability of Macroplastique for stress urinary incontinence in women with previously documented success at 12 months. Substantial, durable results were sustained during 2 years with 84% of patients maintaining significant improvement from their 12-month assessment. Additionally, 67% of the patients implanted with Macroplastique were dry at the 24-month follow-up visit.

VIVUS, Inc. (Nasdaq: VVUS) today announced that Timothy Morris, Chief Financial Officer, will present an overview of the company at two inventment conferences during the month of March.

WaferGen Biosystems, Inc. (OTC Bulletin Board: WGBS), a leading developer of state-of-the-art genetic analysis systems, today announced that Alnoor Shivji, chairman and CEO, will deliver a corporate presentation at the Wall Street Analyst Forum on Friday, March 12, 2010, at The University Club in New York City, at 11:20 a.m. Eastern time.

Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.




"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

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